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Drug & research development » Clinical trials » NCT01147406

Safety and Tolerability Study of N6022 in Healthy Subjects

Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single-Dose Escalation Study Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Effect of N6022 in Healthy Subjects

Clinical Trials gov number: NCT01147406

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Purpose: To evaluate the safety and tolerability of N6022 in healthy subjects.

Phase: 1

Type: Interventional, randomized, double-blind, parallel assignment

Study sponsor: Nivalis Therapeutics, Inc.

  • Subject is healthy

Intervention
N6022

Geographical Location
United States

Number of Participants
≤50 (18-45 years)

Primary Endpoint

Safety and tolerability of single ascending doses of intravenous N6022 in healthy volunteers (7 days)

Secondary Endpoint

Maximum N6022 and metabolite concentrations in plasma within 24 hours of end of administration (24 hours)

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  • Experimental: Active N6022: injectible formulation which will be given at 5, 15 & 45 mg over 1, 3 and 9 minutes respectively, in single ascending doses
  • Placebo Comparator: Placebo: 0.9% normal saline given over 1, 3, or 9 minutes IV bolus
View Trial Results